Study Complete
Sponsor ID
20150288

Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma

Sponsor ID
20150288
Clinicaltrials.gov ID
NCT03023878
EUCTIS ID
N/A
EudraCT ID
2016-002190-35

Study Details

A phase 2, multicenter, open-label, single arm clinical trial in adults with newly diagnosed aggressive high-risk DLBCL.

Additional Study Details

Phase
Phase 2
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
47
Additional Study Details

Protocol Summary

Primary Outcome Measures

Overall incidence and severity of treatment-emergent adverse events

Timeframe: Through study completion for an average of 18 months

Secondary Outcome Measures

Tumor response based on objective response rate.

Timeframe: Through study completion for an average of 18 months

Duration of response

Timeframe: Through study completion for an average of 18 months

Complete response rate

Timeframe: Through study completion for an average of 18 months

Progression free survival

Timeframe: Through study completion for an average of 18 months

Hematopoietic stem cell transplantation rate

Timeframe: Through study completion for an average of 18 months

Overall survival

Timeframe: Through study completion for an average of 18 months

Blinatumomab pharmacokinetic parameters

Timeframe: Through study completion for an average of 18 months

Locations

Location
Status
Contact Us
Location
Research Site
Greenville, SC, United States, 29607
Status
Recruiting
Location
Research Site
Sheffield, United Kingdom, S10 2JF
Status
Recruiting
Location
Research Site
New Brunswick, NJ, United States, 08903
Status
Recruiting
Location
Research Site
Barcelona, Cataluña, Spain, 08003
Status
Recruiting
Location
Research Site
Sault Ste. Marie, ON, Canada, P6B 0A8
Status
Recruiting
Location
Research Site
Oklahoma City, OK, United States, 73104
Status
Recruiting
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